The following data is part of a premarket notification filed by Gigantic International Corp. with the FDA for Sterile Latex Surgeon's Gloves.
| Device ID | K894928 |
| 510k Number | K894928 |
| Device Name: | STERILE LATEX SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | GIGANTIC INTERNATIONAL CORP. 11727 E. WASHINGTON BLVD. Whittier, CA 90606 |
| Contact | James Yang |
| Correspondent | James Yang GIGANTIC INTERNATIONAL CORP. 11727 E. WASHINGTON BLVD. Whittier, CA 90606 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1989-11-15 |